The Standards for Clinical Research set forth some essential principles and processes for the conduct of clinical research in the intramural research programs of the National Institutes of Health. To achieve patient safety, efficient protocol implementation, and effective quality assurance and improvement requires adequate training of clinical investigators and sufficient infrastructure to support their endeavors. Consequently, the Standards should assist both new and experienced investigators as they apply good clinical practice in their research to achieve high-quality results.
The Standards were developed in January 2000 by the Clinical Center Medical Executive Committee, on which all the NIH institutes are represented by their clinical directors. They were endorsed by the scientific directors of the intramural research programs and the institute directors. Based on feedback from intramural clinical research programs and evolving standards within the human subjects research community, the MEC has reviewed and updated the Standards.
The NIH community remains committed to implementation of the Standards and evaluation of their application. It is important that every investigator involved in clinical research at NIH read, understand, and undertake training, as appropriate, to enable her or him to incorporate the Standards into everyday practice. It is equally important that the institutes, individually and collaboratively, assure the availability of all resources essential to the conduct of good clinical research.
The Standards for Clinical Research Within the NIH Intramural Research Program [http://www.cc.nih.gov/ccc/clinicalresearch/] complements the Guidelines for the Conduct of Research in the Intramural Research Program at NIH and A Guide to Training and Mentoring in the Intramural Research Program at NIH [both available at http://www1.od.nih.gov/oir/sourcebook/ethic-conduct/ethical-conduct-toc.htm]. These statements encompass the NIH standards of training, ethics, and conduct for scientists.
John I. Gallin, M.D.
Director, Clinical Center, NIH
Michael M. Gottesman, M.D.
Deputy Director for Intramural Research, NIH
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